Alphatec Spine, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1547-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only

Product Classification:

Class II

Date Initiated: April 10, 2015

Date Posted: May 6, 2015

Recall Number: Z-1547-2015

Event ID: 70958

Reason for Recall:

During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.

Status: Terminated

Product Quantity: (244 units in US and 61 units OUS)

Code Information:

Part Number: 71240-14 Lot: 685904

Distribution Pattern:

Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated